Zero health level. Starting wants to lose the need for invasive blood draw and research support that may lead to new treatments for conditions linked to hormone imbalance or even new health care changes , like individual dosing for hormone restraint.
“One of our investors told us that there are companies building basic technologies and there are companies that build wrappers around that technology; you are creating new technology here,” said co-founder and CEO ULA Rustamova, who has been discussing the company's development since we last checked in with them Last fall When they show on stage in Techcrunch it disrupts as part of the battlefield starting competition.
“The goal is to create a whole new market out of it, right? The same way CGMs [continuous glucose monitors] made. They are literally, none of nothing, create a multi-billion dollar market, ”he continues. “This is, by definition, a whole new category of product of itself – which would inspire people to use the device and the data to create many companies on top of that and have an impact of ripple over the next few decades. “
Step -Step
Building a whole new product category of any drawing can take time. Factor in being a hardware startup, and a medical device to boot, clear level of zero health will not be able to deliver a paradigma shift to how hormones overnight.
This is why the team is also working on a stepping stone single-use product (pictured above in the prototype form), which they expect to be cleared for next year's prescription use-to support consecutive test In the hormone associated with cases of medical use such as fertility (IVF) and low testosterone (TRT).
The current prototype that can be worn contains small needles that provide examples only under the skin to see traces of hormones.
This is a step towards hormone tracking that can be worn that they eventually expect to take to the market – temporarily finished for 2028 – which will be able to pull a continuous measure of things such as progesterone, estrogen and testosterone from Interstitial fluid of the wearer. )
A continuous hormone monitoring device -or, rather, the data it has taken -can play a renewal role in boosting a scientific understanding of the role of hormones in biology of man – similar to CGMs changed diabetes management (and more apart).
But the level of zero health also builds a business-at first is a B2B business, aimed at selling technology to the health care provider networks-so founders work on the development tracks of the development of Twin products to shorten the time-to-man and bridge the gap between the Big Bang Mission and what is currently possible.
“We think we have a source of fact that we can take – which is interstitial fluid,” Rustamova told Techcrunch. “And we think there's an immediate, shorter term product here that we should launch first.
“The idea is continuous -continuing [hormone monitoring] … Is the Holy Grail -that's the future -because it makes sense, in a way because it's frictionless again, you can put it on, and you can classify the same size. But we also understand that, now, we have to enter the market in a way in which we will not try to change the protocol-and do not have a seven-year research question of 'Let's Try and Define this Data'a-Thus the Our first device is really similar to stick stick devices, but it's also a patch. “
Prototype wearable can take measurements throughout the day when worn — the obtaining a series of data points with the purpose of “delivery immediately” for use-cases like IVF, where a woman is It may otherwise need to have many blood drawings to monitor hormone levels.
Rustamova said the team expects to finish clinical trials and secure clearance for single-use temporary monitoring next year — with eyes on getting approval both from the US regulator , the FDA, and a CE marking to allow them to sell in European Healthcare, health care markets (he said they were not sure they could be ahead).
“Hopefully, this year we would like to show some level of touch [between levels of hormones the wearable patch can detect and levels detected via a blood draw] -That's the promise I want to deliver with pre-seed money, ”he added.
CTO and co-founder Irene Jia, tells us the team's goal to show a 90%+ touch to what their patch can pick up compared to measuring hormone levels through a draw of blood.
Risk compared to reward
Although eventually-when we talk about the delay between reading and blood-based discovery by interstitial fluid-Rustamova chimes emphasizes the difference in medical risk between CGMs and hormone monitoring. He points out that the risk for a person with diabetes (i.e., if reading glucose in the blood is delayed or turned off) is likely to be very high, whereas hormone monitoring is usually not high stakes.
“For glucose, you have the potential deadly consequences of giving the wrong reading or having that delay … [but when it comes to hormone monitoring] The risk of having a slight deviation or kind of touch that is less tight, ”he told us. “Obviously, we'll try and be linked as much as possible – but … there's a different hazard profile here.” He also noted that the first CGMs in the market have a lower contact with blood readings than these devices do now.
The suggestion is that the team's goal is to continue to raise the bar to the accuracy. Which – perhaps – clues for the reason that investors are diligently picaging with the early cycle of this medtech start – with potential rewards compared to the risks that are -kewed in a positive direction.
Other – no doubt – the benefit -beneficial factor here is that the level of zero health is not just focused on women's health issues; Monitoring male hormones is a major piece of initial business plan. (And it remains the case that most tech investors are still men who put bets on solving problems that speak their interests.)
The pre-seed funding round of zero health level is led by European VC, redalpine. The Hax (SOSV), Entrepreneur First (EF), and Industry Experts also contributed to the cycle -with SOSV accepted that the start of his Deeptech/Hardware Hax Accelerator Program, and Rustamova has become a Ef alum.
Commenting on a statement, Philip Kneis, investor in redalpine and a level of zero health member board, said: “We did it for blood pressure and do it again for hormones. measuring hormone is one of the divine grains of diagnostics, and as the main transfers in engineering science, we are not more excited to back level zero health on their mission to transform hormone monitoring along with Their novel Biosensor – puts the way for a new period of personal management. “
